Adverse events associated with benznidazole treatment for Chagas disease in children and adults

Abstract

Aims: Chagas disease (ChD) affects approximately 7 million people in Latin America,with benznidazole being the most commonly used treatment.Methods: Data from a retrospective cohort study in Argentina, covering January1980 to July 2019, was reanalysed to identify and characterize benznidazole-relatedadverse drug reactions (ADRs).Results: The study included 518 patients: 449 children and 69 adults (median age inchildren: 4 years; adults: 25 years; age ranges: 1 month–17.75 years and 18–59 years, respectively). The median benznidazole doses received were 6.6 mg/kg/day for at least 60 days in children and 5.6 mg/kg/day for a median of 31 days inadults. Overall, 29.34% (152/518) of patients developed benznidazole-related ADRs,with an incidence of 25.83% (116/449) in children and 52.17% (36/69) in adults(odds ratio [OR] = 0.32, 95% confidence interval [CI] = 0.19–0.54, P < .001). Theincidence rate was 177 cases per 1000 person-years (95% CI = 145–214) in childrenand 537 per 1000 person-years (95% CI = 360–771) in adults. There were 240 ADRsidentified, primarily mild to moderate. Severe ADRs occurred in 1.11% (5/449) ofchildren and 1.45% (1/69) of adults. The skin was the most affected system. A totalof 10.23% (53/518) of patients discontinued treatment. More adults than childrendiscontinued treatment (OR = 3.36, 95% CI = 1.7–6.4, P < .001).Conclusions: Although 29.34% of patients experienced ADRs, most were mild tomoderate, indicating a manageable safety profile for benznidazole. While optimizeddosing schedules and new drugs are needed, avoiding benznidazole solely due tosafety concerns is not justified.